Abbott's Reproductive Endocrinology Control Set may give incorrect pregnancy test results if stored in a refrigerator that gets too cold. Recalled due to temperature excursions on Jan 8, 2:00 PM.
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Abbott's Reproductive Endocrinology Control Set for pregnancy testing was recalled because refrigerators storing them experienced temperature drops below safe levels, which could cause incorrect or delayed test results. This affects customers who use the control set to verify test accuracy.
The control set was stored in a refrigerator that dropped below 35.6°F (2°C) for up to 60 minutes on January 8, 2024. This temperature excursion could cause the test to give incorrect results or delay results, potentially leading to wrong pregnancy conclusions.
Pregnancy test users who purchased the Abbott Reproductive Endocrinology Control Set from McKesson. Those using the control set to verify test accuracy are most at risk.
The product is labeled 'Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive'. Look for Catalogue Number 5011 and Lot No. KN00589.
Review your refrigerator's temperature logs to ensure it stayed within 35.6-46.4°F (2-8°C) during storage.
If you used the control set, confirm test results with a new test to avoid incorrect conclusions.
The control set was stored in a refrigerator that dropped below 35.6°F (2°C) for up to 60 minutes on January 8, 2024, which could cause incorrect or delayed test results.
Look for the product name 'Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive' with Catalogue Number 5011 and Lot No. KN00589.
No, the recall does not require discarding the product. Check your refrigerator's temperature history and verify test results if used.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1312-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1312-2024 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
